Jobs that Crossed my Desk –Sept. 20 through Sept. 28, 2008Jobs That Crossed Desk Through Sept. 28

***************************************************** Contact the person whose information appears at the top of each listing.

Ronald H. Coelyn E-mail: rcoelyn@coelyngroup.com Phone: 817-424-3652 web: http://www.coelyngroup.com

There are 2 positions with the first client, which is a Company that has developed and is selling an exciting new series of human diagnostic systems to perform tests that have previously been unavailable. It has a break-through technology and a strong, proprietary position.

President & Chief Executive Officer

The President & Chief Executive Officer will be replacing a scientific founder with the objective of leading the commercialization of the Company's technologies. He/she would ideally have a sales, marketing and business development background from the human diagnostics sector. He/she will also have experience with a public company as there are plans to complete an IPO when market conditions permit.

Board Member/Corporate Director

The Company intends to expand its Board of Directors and is seeking someone with a strong background in human diagnostics. As mentioned above, while the Company is currently private, experience with publicly traded companies is required.

The Company is privately held and supported by a prestigious group of venture capital investors.

The Company is located in the Midwestern United States.

There are 2 positions with the second client as well, which is a Company that has developed a proprietary system which permits aortic valve replacement on a beating heart in a procedure performed entirely in the cardiac catheterization laboratory. This new technology aims to completely eliminate the need for open-chest surgery and any form of cardiac support during the aortic valve replacement procedure. These advances are expected to make heart valve replacement available to patients previously ineligible for this life saving therapy.

Vice President, Clinical Affairs

5/20/2023 1

The Vice President, Clinical Affairs is a new position. The ideal candidate will be expected to have significant experience in the interventional cardiology and/or cardiac surgery/heart valves sector(s). He/she will have broad functional responsibility for all aspects of the design, implementation, execution and management of complex, randomized clinical trials programs.

Senior Director, Global Reimbursement

The Senior Director, Global Reimbursement is a new position. The ideal candidate will be expected to lead global pricing and reimbursement strategy and the development and management of global price policies for assigned strategic products.

The Company is privately held and supported by a prestigious group of venture capital investors.

The positions can be located anywhere in the domestic United States, notwithstanding a preference for our client's headquarters office in Northern California.

We are seeking individuals with impeccable personal and professional reputations and unquestioned integrity; people who are relentless in the pursuit of lofty goals; and finally, people whose track record of accomplishments and contributions are unambiguously clear.

***************************************************** Robin YonemuraClinical Resource Group760-597-1700 x106robin@srgr.com

Subject: Regional QA Auditor position

Here is the JD and a brief questionnaire for your colleagues that youthought might have an interest in this position. It is a great company (beenmy client a long time) based her in Socal; but the position as I mentionedis work from home and travel to sites. Base 95-97K with full benefits.Please have them contact me directly and I can tell them more.***************************************************** Paula RutledgePresidentLegacy MedSearchRetained Recruitment Solutions<http://www.linkedin.com/in/paularutledge> View Paula's LinkedIn Profile<http://www.legacymedsearch.com/find-position.php> View Open Positions <http://www.legacymedsearch.com/> www.LegacyMedSearch.com

407-898-4440

5/20/2023 2

Director of Research, Development and Commercialization for Midwest,mid-sized company with a diverse portfolio of Class 3 implantable andinterventional devices.

Any Class III experience is acceptable (Ortho, MIS, CV, Interventional,Surgery), as in Pharmaceutical and or combination drug/device products.

Here's the tricky part - the "soft skills" are absolutely critical as isprior experience leading the R&D cycle and bringing a product to market.

Quick and dirty parameters:

1. 10 years prior management as the #1 or #2 on a successful product launchfrom whiteboard to commercialization.

2. DRIVER personality with a sense of urgency, credibility, and very strongmanagement skills (product, program, people). A LEADER.

3. No more than 2 voluntary job changes in 10 years (this is a 3-5 yearproject and stability is critical).

4. Foresight to "stay the course" in what will surely be a surreptitiouspath with parallel development projects leading to a launch in 3-5 years.5. Degree in engineering, life science or similar (MBA would be great).International launch would also be great.

6. Must have overseen budgets of $2M+, teams of at least 6 direct reports,and be able to do verbal presentations to the Board.

***************************************************** Andrew YoungelsonKey Recruit Inc.www.keyrecruit.comDirector Business Development / Sales

Date Posted:     9/15/2008       Job Id:     1647       Company:     Our company is a clinical research organization. We are ahighly dedicated development association of devoted research professionalsfocused on delivering Drug Development Services, Clinical Trials Managementand Site Services for the pharmaceutical and biotechnology industries. Ourcompany's forward thinking management, combined with progressive researchopportunities, allow us to successfully care for patients and studysubjects. We actively partake in and support the growing need for improved

5/20/2023 3

pain management solutions. We also center on addressing issues surroundingsubstance abuse, addiction, sleep medication, and the cultural and politicalapproaches towards constant pain management using opioids.       Location:     Virtual Home Office       Reports To:     Executive Director Business Development       Salary:     $120-$140k with a 1% bonus on new work brought in.       Education:     Bachelors degree in scientific discipline.       Requirements:     Required Skills: Excellent communication skills(interpersonal, written, verbal). Experienced negotiation skills. Formalpresentation skills. Ability to perform overnight business travel, up to60%. Excellent persuasive/selling skills. Excellent Computer Skills toinclude Word, Excel, PowerPoint, Database. Required Experience: Familiaritywith pharmaceutical drug development process specifically CNS. Somemanagement experience helpful. Minimum of three years direct experience inconsultative sales (preferably in CRO or related service industry). Provenhistory of developing qualified leads and meeting quota. Comfortableconversing with executive business decision makers. Successful at distillingtechnical features into compelling business benefits. Independent,self-motivated and success driven, yet able and willing to take direction.Strong organizational skills and attention to detail.       Duties:     Job Description: Secures contract awards based uponpredetermined financial targets by cultivating and maintaining clientrelationships. Additional responsibility for global accounts.

PRIMARY JOB FUNCTIONS: Identifies and qualifies business opportunitiesrelated to potential projects requiring clinical research services both fortarget and exploratory accounts. Secures client meetings. Obtains requestsfor proposals. Assists in proposal development and facilitates presentationsat client site. Secures contract awards based on above efforts and salestargets. Assists with maintaining client satisfaction. Provides project teamsupport as appropriate. Monitors and assists with change orders related tocurrent contracts. All other projects as assigned.

As always thanks for passing on!Visit www.keyrecruit.com  to view other openings.  

If Interested

You should upload you resume and send me a copy as a Word document And tellme your current salary, Include a cover letter explaining why you would be a

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good fit for this position using the using the keywords in the jobrequirements as a guide.  Letter should include how your work in the past isrelative to client needs in the present. "Familiarity with pharmaceuticaldrug development process specifically CNS."***************************************************** Nick Osborne San Jose, CAosbornen@yahoo.comIf anyone is interested in one of these positions they can e-mail me with "Aptina Opportunity" in the subject line and I'll do what I can tohelp.This list, along with more details about the positions, is available at: http://www.aptina.com/careers/listings.jsp,

> * Analog Layout Engineer> * Applications Engineer> * CAD Engineer> * CAD Supervisor> * Characterization Engineer> * Failure Analysis Engineer> * Field Applications Engineer> * Image Scientist> * Image Test Engineer> * Imager Device Characterization & Reliability Engineer> * Imaging Characterization Engineer> * Imaging Product Engineer> * Imaging Product Engineer> * Physical Implementation Engineer> * Pixel Development Engineer> * Senior Applications Engineer> * Senior Applications Engineer> * Senior CMOS Image Sensor Product Engineer> * Senior Image Processing Engineer> * Senior Imager Pixel Development Engineer> * Senior Imaging Product Engineer> * Test Engineer> * Test Engineer> * Analog/Mixed Signal Design Engineer> * Business Systems Manager> * CFA Micro Lens Engineer> * Financial Analysis Manager> * Financial Analyst> * General Ledger Accountant> * Imager BEOL Senior Process Integration Engineer (Boise)> * Imager FEOL Senior Process Integration Engineer (Boise)> * Imager New Part Process Integration Engineer

5/20/2023 5

> * Imager Package Integration Engineer> * Micro-Optics Process Integration Engineer> * Operations Manager - Assembly and Test> * Project Manager> * Project Manager> * Senior Analog Layout Engineer> * Senior Applications Engineer> * Senior Embedded Firmware Engineer> * Senior Imager Device Engineer (Boise)> * Senior Imaging Flash Device Engineer> * Senior Imager Pixel Development Engineer> * Senior Lens Design Lead> * Senior Physical Implementation Engineer> * Software Applications Engineer> * SRAM Device Engineer> * Treasury Manager***************************************************** Postings from Dawn Mischler if you are interested and qualified you can contact her at dmischler@searchpath.com

Regulatory Affairs Manager (San Francisco, Bay area)Provide regulatory support and guidance to project teams and regulatory staff. Prepare and submit FDA and European submissions for approval. Manage process from development of regulatory strategies thru to approval. Ensure compliance with all U.S. and international regulatoryrequirements pertaining to product approval. Recruit retain and develop regulatory staff to m Essential Functions:1. Work with Director to devise regulatory strategies to ensure rapidand timely approval of devices.2. Interpret existing or new regulatory requirements as they relate tocompany products and procedures, clinical studies, testing, or recordskeeping. 3. Review, analyze and approve technical data generated by Research andDevelopment, Manufacturing, Marketing, Clinical Research, QualityAssurance or other related departments for filing purposes.4. Prepare US and International regulatory submissions, including, butnot limited to IDE/IDE Supplements, PMA Supplements, Annual Reports,Technical Files, and Design Dossiers and Change Notices. 5. Review and advise on labeling, product claims, training materials,publications, press releases or marketing programs to ensure compliancewith regulations.6. Advise on international product registration and export approvalrequirements. 7. Participate in the drafting and submission of a first of a kind PMA.

Experience:

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Bachelor's Degree in Science of Life Science or Engineering or equivalent (MS preferred)Must have 6-8 years experience working in a Regulatory Environment preparing submissions for Class III US, EU medical devices and a successful track recordMust have 6-8 years experience working in a Regulatory Environment preparing submissions for Class III US, EU medical devices and a successful track record.Must have a solid knowledge of Class III US and European regulatory processes.Must have extensive experience in the preparation, and submission of Pre-IDEs, IDEs, PMA supplements, Technical Files, Dossiers and amendments and a successful track record. Must be able to independently research regulatory issues and provide regulatory solutions to project teams.

Company is filing a first of its kind PMA in 2009 and needs Regulatory Affairs Manager Immediately!Aggressive Salary for the right candidate!If you are interested in this remarkable opportunity or know someone whois please forward your resume to dmischler@searchpath.com.

Senior Regulatory Affairs Associate (Medical Device)Menlo Park, Ca (San Francisco Bay Area)Competitive Salary and Benefits for the right candidate!

Purpose: Prepare and submit FDA and European submissions for approval.Provide RA support and guidance to project team, R&D and Marketing.Ensure compliance with all U.S. and international regulatoryrequirements pertaining to product approval.

Daily Functions:

Work with management to devise regulatory strategies to ensure rapid and timely approval of devicesParticipate in the drafting and submission of a first of a kind PMAPrepare US and International regulatory submissions, including, but not limited to IDE/IDE Supplements, PMA Supplements, Annual Reports,Technical Files, and Design Dossiers and Change NoticesReview and advise on labeling, product claims, training materials, publications, press releases or marketing programs to ensure compliance with regulations.Advise on international product registration and export approval requirements.

Education/Experience:A Bachelor's Degree in Science of Life Science or Engineering or equivalent (MS preferred)Must have 4-6 years experience working in a Regulatory Environment preparing submissions for Class III US, EU medical devices and a successful track record. Must have a solid knowledge of Class III US and European regulatory processes.Must have extensive experience in the preparation, and submission of Pre-IDEs, IDEs, PMA supplements, Technical Files, Dossiers and amendments and a successful track record. Must be able to independently research regulatory issues and provide regulatory solutions to

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project teams.Cardio, implantable, stents, valves, catheter experience is requiredPMA experience is a plus, but no PMA experience is needed – company will train on this.Do these qualifications sound like your previous background?Do you know of anyone who fits this job description? For more details and to be considered for this opportunity please forward your resume to ***************************************************** Laurie KefflerTechnical Recruiter(480) 345-2036 x.119swaits@tacworldwide.com Visit us at http://www.tacworldwide.com/

Regulatory Affairs Manager

Location: Milpitas, CA

Salary: $110-115K DOE

Direct Hire/Full Time position

Relocation assistance is available up to $5000

***2 references required - please provide with your resume submittal(Contact name, title, company, email, phone number/s)

DESCRIPTION:

Plan, organize and coordinate regulatory submissions/applications and ensurequality and timely regulatory support is provided to obtain marketingapprovals for the new products. Maintain marketability of existing products.Ensure departmental objectives are met. Work with regulatory personnelworldwide to provide expertise and experience, and assist in the preparationand submission of registration materials and to exchange regulatoryinformation and new product development data.May participate in project team meetings and provide relevant regulatoryinput toward product approval objectives. Make decisions and take actionswitch are required to carry out job duties and assure compliance with allapplicable international, federal, state and local regulations.

1. Develop and execute regulatory plans for complex projects including newproducts and maintenance of licenses/authorizations for existing marketingauthorizations.2. Represent the RA function on assigned cross-functional project teams. 3. Monitor applicable regulatory requirements; assure compliance with

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company and external standards.4. Manage and resolve submission issues. Advise on issues of product orprocess quality and risk management.5. Establish appropriate communication within RA and other functionsprimarily at project level.6. Develop and document sound regulatory decisions and justifications.7. Ensure project teams, business objectives, and deliverables are alignedwith regulatory strategy.

REQUIREMENTS:

* Bachelors Degree in Electrical, Electronics or related field. * Minimum 5 years experience in the medical equipment/deviceregulatory affairs. * Sound basis of regulatory knowledge with specific and proven abilityto prepare device applications for the US (i.e.: FDA, IDE's, 510(s), EU, andother regions). * Ability to manage complex projects and timelines within a projectteam environment. * Ability to independently identify compliance risks and escalate whennecessary. * Strong verbal and written communication skills. * Strong computer aptitude.

If the timing or position is not right for you & you know someone else thatmight be interested, please forward this email to them.

If interested in pursuing this job, please reply with the following at yourfirst opportunity:

. Most current resume in Word format - we never present to a clientwithout first discussing with you

. Current location (city & state)

. Availability to interview (i.e. immediately, 24 hours notice, 72hours notice, etc)

. Availability to start upon receipt of an offer (i.e. immediately,2 weeks, etc)

. Salary requirements ***************************************************** Please send resume as an attachment to wd_darshana@hotmail.com

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There is immediate opening for principle electrical engineer for an implantable device company, located near Mountain View CA, with secure IP, solid VC backing, and product in early stage trials showing great promise. Experience with leading complete electrical design for microprocessor based, embedded medical device at system or board level (as opposed to ASIC design) is required. RF or wireless design experience, a big plus.

***************************************************** Bonnie LewinsteinSearch ConsultantGlobal Recruiters of West Palm Beach12008 South Shore Blvd., Suite 206Wellington, FL 33414(561) 422-5150 Phone(440) 425-5150 Faxblewinstein@grnwestpalmbeach.com

I am currently in the process of confidentially identifying selected individuals for some of my best clients. Please let me know if you know someone that might be interested in exploring any of these opportunities. Please understand that any conversations will be held in the strictest of confidence.

Available Positions:Marketing Project Manager-CA #564 Marketing Manager- CA #509Marketing Manager-Molecular Diagnostics #549

Detail of Positions Below:__________________________________________________________

Marketing Project Manager-CA #564

A major global pharmaceutical biotech and diagnostics company is searching for a Marketing Project Manager to join their California location. Reporting to the Director of Global Marketing the Marketing Project Manager will provide commercial leadership for blood screening assay development and marketing programs. The incumbent will be responsible for new products, current products, and product extensions.

Key Duties, Activities and Responsibilities:

- Represent Marketing as a subject matter expert in achieving commercialization objectives by driving and maintaining schedules for registrations on clinical trials

of new and mature products globally.

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- Act as the subject matter expert for product registration cycles with minimum impact to customers globally.

- Collaborate with Regulatory Affairs and other functions as required to execute conversions, renewals and maintain allocation plan to ensure the needs of the

customers are met.

- Work collaboratively with Research , Development, Operations, Quality, Regulatory, Scientific Affairs and other departments to ensure registration project

priorities and decisions are consistent between teams and corporate strategic plans.

- Support establishment and maintenance of project budget, timeline, resource usage and forecast, issues and resolutions, risks and mitigation actions, and

amendment tracking. Address variances by developing action plans with Regulatory, Clinical and Scientific Affairs and R&D to ensure that project stays on

schedule.

- Responsible for tracking progress against plan, consolidating weekly status updates, communicating progress reports to Marketing team, Diagnostic

Commercial Council and other vested parties.

- Oversee resource requirements for multiple projects, identify and promptly bring to resolution issues forcing changes to the Project Plan.

- Identifies potential bottlenecks or delays in the programs and drives efforts to ensure projects stay on schedule.

- Monitors, facilitates and prioritizes activities to meet project schedules. Activities include: communicating project status and critical path items to Sr.

Management, developing and implementing timeline plans for product registration availability, monitoring project resources, convening periodic meetings, issuing

meeting agendas and minutes, monitoring team performance goals, and assisting in resolution of problems/critical issues. Works with cross-functional teams

consisting of 5 -15 people.

Work Experience, Skills and Education Required:

- Bachelor's degree in Science, Engineering, Business Administration or related field, or

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equivalent combination of education and work-related experience.

- Advanced Science or Business degree preferred.

- Prior experience in the Biotech industry required and/or Diagnostics/IVD preferred.

- Prior experience project managing registrations cycles highly desired.

- 8 - 10 years or more applicable experience with a minimum of 5 years demonstrated successful cross functional project management experience.

- Broad knowledge and experience in various areas of life science and product discovery research desired.

- Working knowledge of worldwide IVD regulatory processes and clinical evaluations desired

- Must have strong verbal and written communication skills with a strong ability to plan, organize and effectively present to Senior Management on project

progress, challenges if any and ability to make necessary recommendations for moving forward.

- Must have strong negotiation, facilitation and diplomacy skills to manage conflicting views and expectations.

- Proficiency in complex financial modeling required.

- Strong leadership potential.

- Position requires flexible hours due to continuous workload fluctuations.

- Strong project management experience with multi cross-functional teams.

- Demonstrated ability to drive projects to completion and get results.

- Willingness to travel up to 20% of the time (both domestically and internationally).

- Proficiency in Microsoft Project.

__________________________________________________________

Marketing Manager-CA#509

A Global healthcare diagnostics company that offers laboratory testing services and products to hospitals, commercial laboratories, physicians and public health agencies to assist with the

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diagnosis, treatment and management of infectious diseases seeks a Marketing Manager for their California location. The primary responsibility of this position is to design, implement and manage marketing campaigns, develop business strategies, and develop and manage assigned product portfolios for the company's laboratory services unit, which markets esoteric infectious disease testing services and autoimmune testing services directly to hospitals and commercial reference laboratories and indirectly to physician specialists in the United States. This position will have responsibility for infectious disease and other testing in all market segments and will maintain a liaison role with the Diagnostics marketing team. Supports applicable regulations including ISO, Local, State, and/or Federal requirements.

Key Duties, Activities and Responsibilities:

-Establish and implement plans to achieve revenue, profit, and growth objectives in conjunction with sales and marketing management and in concert with company business plans and strategies

-Develop marketing programs and campaigns that support the achievement of the Laboratory Services annual revenue plan.

-Develop and implement tactical programs that serve to raise the awareness of Focus’s menu, expertise, and related services in the clinical market place in general

and among influential thought leaders and innovators in the clinical marketplace and drives growth for the company

-Build and maintain comprehensive competitive analyses on the overall reference laboratory industry and menu-specific competitors; establish competitive

positioning statements and tactics based on these data

-Work with Laboratory Operations, R&D, Sales and the Marketing team to launch new assays and services to both current and potential clients; establish a

system to monitor test/service usage and to maximize account penetration and cross-selling opportunities.

-Coordinate, as needed, marketing strategies and execution plans with both the diagnostic products division of the company and with Quest Diagnostics

counterparts.

-Work closely with Finance, Sales, Operations and Marketing team to appropriately determine pricing strategies, levels while maintaining targeted profitability

levels and business objectives.

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-Serve as the internal point person to receive and to investigate new test and service recommendations from the field sales organization.

- Actively promote brand identity as articulated in the marketing plan and in conjunction with Quest Diagnostics.

-Serve as the commercial laboratory industry and market expert for Focus Diagnostics.

-Identify industry professionals, laboratorians, and Infectious Disease Physicians to serve as advocates for Focus’ Reference Laboratory and as advisors to the

marketing department. These individuals should be open to stimulating the “word of mouth” promotion of the laboratory.

-Work with Focus’s Scientific Staff to develop a plan that will allow them to become more integrated into the medical community of select institutions. This effort

is to include routine on-site visits, participation in grand rounds, educational sessions, etc.

-Routinely call on clients to better understand the market as well as build relationships with key accounts

-Working with Marketing Communications to explore opportunities to promote the availability of Focus’s laboratory services via various electronic newsletters

and web-based informational sources such as Clin Micro Net, Pro Med, Medscape, etc.

-Develop training materials, educational materials and training presentations for field sales as well as internal groups such as client services

-Develop annual Laboratory Services volume and revenue forecast for the Commercial and Hospital segments.

-Work with Marketing Communications on all aspects of promotion: tradeshows, advertising, press releases, web content, catalogs, brochures, technical

summaries, field sales education (both traditional and web-based avenues), etc.

-Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and

practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the

employees. Also responsible to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of

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safety directives and procedures will be handled in accordance with the established Company disciplinary process.

-Perform other duties as assigned.

Work Experience, Skills and Education Required

-Bachelor's degree (B. A.) or (B.S.) from four-year college or university and 2-3 years sales and/or marketing experience in the diagnostic, healthcare, or

reference laboratory industries.

-Masters in Business Administration preferred.

-Knowledge of the infectious disease marketplace including working knowledge of the industry players, publications, conventions and trade shows is highly

preferred.

-Experience with new product launches, market segmentation, and branding.

-Knowledge of diagnostic, laboratory and/or scientific products and services is needed to be successful in this position.

-Highly effective people skills with an excellent team player reputation and enthusiastic attitude are key attributes for this position.

-Ability to work effectively in a cross-functional environment is very important.

-Very strong communications skills both verbally and written. Proficient working knowledge of MS Word, Excel, PowerPoint and Access.

-Able to travel on an as needed basis.

-This person will be self-motivated, creative, intellectually curious, and able to work independently

__________________________________________________________

Marketing Manager-Molecular Diagnostics #549

A leading company that manufactures and distributes high-end analytical instruments, laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions seeks a Marketing Manager-Molecular Diagnostics.

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Key Duties, Activities and Responsibilities:

- Responsible for the creation and execution of marketing and strategic sourcing strategies to support the growing molecular initiative in the US healthcare sector.

This position will focus on leveraging existing products in the Molecular Diagnostics portfolio as well as adding new, opportunistic products in 2008

- Responsible for the Execution and on-going refinement of the 2008 Molecular Diagnostic Marketing Plan.

- Creation of marketing support collateral for the Healthcare Molecular Diagnostics sales team.

- Develop and implement tactical programs that serve to raise the awareness of the company's , expertise, and related services in the clinical market place in

general and among influential thought leaders and innovators in the clinical marketplace and drives growth for the company

- Build and maintain comprehensive competitive analyses on the overall Molecular Diagnostic industry and menu-specific competitors; establish competitive

positioning statements and tactics based on these data.

- Direct engagement with the US Molecular Diagnostics Specialist sales team. Relationship management of all Molecular Diagnostic suppliers.

- Work closely with Finance, Sales, Operations and Marketing team to oversee/update financial performance of the Molecular Diagnostic portfolio. Determine

pricing strategies levels while maintaining targeted profitability levels and business objectives.

- Serve as the internal point person to receive and to investigate new test and service recommendations from the field sales organization.

- Actively promote brand identity as articulated in the marketing plan

- Routinely call on clients to better understand the market as well as build relationships with key accounts.

- Develop training materials, educational materials and training presentations for field sales as well as internal groups such as client services.

- Work with Marketing Communications on all aspects of promotion: tradeshows,

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advertising, press releases, web content, catalogs, brochures, technical

summaries, field sales education (both traditional and web-based avenues), etc.

- Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions as well as correcting unsafe work habits and

practices

Work Experience, Skills and Education Required:

- BS or greater degree in a related scientific or engineering discipline and 8 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD or Pharmaceutical firm-Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Six Sigma, Etc)

-Highly effective communication skills at senior management levels both written and verbal. The ability to effectively communicate with internal and externalcustomers and stakeholders including regulatory authorities-Thorough knowledge of quality systems regulations. (ISO; FDA, PAL, etc.) -Demonstrated ability to motivate and effectively manage associates -Excellent analytical, technical, and problem solving skills -Excellent meeting and presentation skills -Ability to perform multiple tasks and to prioritize work load -Effectively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties -Ability to work in and to direct teams to obtain results -Knowledge and experience in financial management, planning, and organizational skills -Self motivated/directed ***************************************************** David Obad, Medical Device Recruiter, NCompass Consulting, www.ncompassinc.com\415.738.7878 - Office415.738.7878 - Facsimile866.949.7878 david.obad@ncompassinc.comNCompass: Bay Area Medical Device Opportunities (Manufacturing/Operations)Hi Marc, I wanted to touch base with you on our latest positions. Please click on a position below to view the job description:

Job 966 - Package Engineering Manager - Orthopedic - SunnyvaleJob 958 - Sr Advanced Process Engineer - Stent - Menlo ParkJob 964 - Sr Manufacturing Process Engineer - Hearing Technology - NewarkJob 957 - Sr Tooling Engineer - Orthopedic - SunnyvaleJob 940 - Sr Manufacturing Engineer - Respiratory - Redwood City

Please let me know if you have any questions, and feel free to forward my information along to anyone who may be interested in learning more.

Thank you for giving me the opportunity to network with you.

5/20/2023 17

Best, David____________________David ObadMedical Device RecruiterNCompass Consultingwww.ncompassinc.com415.738.7878 - Office415.738.7878 - Facsimile866.949.7878 - Toll Free*****************************************************

Daniel BiggarLeading Edge Medicalwww.LeadingEdgeMedical.comOffice # 303-449-9300 ext. 3Cell # 720-938-7959 I wanted to send over some Bay area openings:

1). Dir. Clinical Affairs

. Identify, plan, develop, implement and manage clinical trials that expandindications based on requirements of the most appropriate regulatory path.

. Communicate and collaborate with Medical Advisory Board and principalinvestigators to design protocols for clinical trials that satisfy thescientific needs of the medical community as well as commercializationneeds.

. Collaborate with senior management team and Marketing ensuring clinicaltrial designs support evidence based data needs for publication,reimbursement and marketing initiatives.

. Oversee all aspects of clinical trial operations including evaluating andcontracting with appropriate CRO, vendors & clinical investigators/sites,develop and manage clinical budgets including study supply requirement,coordinate the development of protocol, data management plan, statisticalanalysis plan and clinical report writing, as well as ensuring compliancewith clinical regulations such as GCP, ICH.

. Serve as the primary internal contact for outside regulatory consultant tocoordinate and support all regulatory documentation and process, includingIRB approval, regulatory filing, SOP development and implementation.

. Take a leadership role together with Marketing in organizing MedicalAdvisory Board meetings, communications, publications, presentations, etc.

. Partner with research & development and marketing to drive next generationproduct definition and corporate strategies.

. As a member of executive staff, develop cross-functional strategies toenhance the business plan.

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2). Sr. Principal Embedded SW Engineer for an active implantable medicaldevice company in the Bay. The company is undergoing an expansion of theirengineering operations due to impressive clinical data of their cutting edgeNeuromodulation technology. Anyone interested in hearing more about thisopportunity in a rapidly growing startup company is urged to contact LeadingEdge Medical Search for more information. Please contact only if youconsider yourself a top performing engineer that has the ability to writeefficient code in a low power electromechanical device.

We also have other opening in Regulatory Affairs, Clinical Affairs, ClinicalMonitoring, Field Clinical Engineering and QA.*****************************************************

Jobs Sept. 13-20Jim Brown Associates15 Southwind CircleMarina Bay – The BreakersRichmond, CA 94804-7405Phone: (510) 235-4472FAX: (510) 235-4482e-mail: jim@jimbrownassociates.com

Position Title: Product Manager/Senior Product ManagerDepartment: MarketingLocation: San Francisco Bay AreaReports to: Director, Commercial Operations

Summary:The incumbent develops specific marketing plans for products or therapeutic areas within the organization. Interprets and translates scientific clinical data into commercial implications. Conducts and manages primary and secondary market research projects, including labeling and advertising. Analyzes data and makes strategic recommendations. Provides marketing insight and direction to optimize new product launches. Recommends pricing strategies, and monitors budget and expenditures. Ensures product placement and development corresponds to market needs. May develop short and long-range strategies for product expansion. Represents marketing group on cross-functional team interfacing with product development, production and manufacturing to develop new products or enhance existing products or product lines.

Responsibilities: Build marketing plans Manage market research Coordinate involvement in medical conventions Invent creative medical education initiatives Design sales and marketing materials Work with medical thought leaders

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Translate scientific clinical data into commercially useful material Establish pricing strategies Analyze data and make strategic recommendations Develop budgets and monitor expenditures Interface with product development, regulatory, and legal

Required skills and experience: 3-5 years of pharmaceutical sales and marketing management experience,

including 1-2 years product management experience Knowledge of pharmaceutical market research techniques Set clear and achievable objectives Map strategies to achieve objectives Model financial plans Motivate others Analytical / creative thinker Master degree preferred

***************************************************** Please send resume to Darshana Nadkarni at wd_darshana@hotmail.com

CFO – Surgical device company located in bay area, has an openingfor a CFO. Experience in a publicly traded company and knowledge of SEC rules and regulations is essential.

Responsibilities include planning, directing, andcontrolling the financial, strategic planning, and administrativeaffairs of the company, leading and directing the Human Resources andIT activities of the company, ensure legal compliance with regulatoryagencies, direct timely and accurate preparation of all financial andmanagement reports, including income statements, balance sheets,reports to shareholders, tax returns, and reports for governmentregulatory agencies in accordance with the requirements of a publiclytraded company, assist the CEO to issue press releases, assist seniormanagement in developing budget and profit and loss models for futureperiods, and oversee compilations of actual operational and financialresults, to include budgeting, tax and audit activities.

***************************************************** Please send resumes or leads to Darshana Nadkarni at wd_darshana@hotmail.com.

Director of Systems Engineering and Director of Program Management

Medical device company located in Ottawa, Canada has these openings. They have neuro modulation device with a HUGE market opportunity, ex-Guidant leadership team and is in a serene location with low standard

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of living. Systems Engineering Director position can be located in the US. Some ability to speak in French, would be a huge plus.***************************************************** There is an extensive list of positions from this new addition to our recruiters. Individual jobs are associated with straight line while submissions are separated with string of stars.

ContactJarboe & Associates janetjarboe@qwest.net(office) 970-669-2600 970-689-2962 (mobile)

Associate Director/Director Regulatory Affairs (Illinois)Details available Monday, September 22nd Senior Director, Regulatory Affairs____________________________________________________________________(California)Reporting to the Vice President Regulatory Affairs, the successful candidate will provide regulatory strategy, expertise and leadership for development stage fibrosis monoclonal antibody program. Candidate will oversee all regulatory activities pertaining to the fibrosis program. Responsibilities: -Develop and implement regulatory strategies to facilitate the progress of Phase I through Phase IV development of drugs in the fibrosis program across multiple indications. -Provide regulatory expertise to development projects teams, developing regulatory strategy and execution of strategic plans that are in support of project goals and timelines. -Assume a key leadership role providing regulatory guidance to the fibrosis development, operation and marketing groups. -Direct the preparation of well-organized, scientifically sound regulatory submissions (domestic and international), to include INDs, CTAs, NDAs, BLAs, MAAs, DMFs, etc. and required amendments that comply with applicable regulatory requirements. -Act as a credible, influential and well respected spokesperson for interactions and negotiations with regulatory authorities and corporate partners. -Anticipate changes in the regulatory affairs environment and approval requirements to maximize the likelihood of drug approvals. -Recommend regulatory policies to assure adherence to FDA requirements. Contribute to the modification, development and implementation of company practices and policies for regulatory affairs. -Provides regulatory expertise and policy support for good pharmaceutical practices (GCPs, GMPs, and GLPs). Qualifications: -A s t r o n g s c i e n t i f i c b a c k g r o u n d w i t h a t l e a s t a b a c h e l o r ' s d e g r e e . - M i n i m u m o f 1 0 y e a r s o f r e g u l a t o r y a f f a i r s e x p e r i e n c e i n t h e r a p e u t i c s a n d a h a n d s - o n a p p r o a c h t o l e a d i n g a n d m a n a g i n g r e g u l a t o r y a c t i v i t i e s . -P r e v i o u s r e g u l a t o r y e x p e r i e n c e i n

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d e v e l o p i n g a b i o l o g i c a l t h e r a p e u t i c p r o d u c t . -P r e v i o u s e x p e r i e n c e i n p r e p a r i n g a n d s u c c e s s f u l l y f i l i n g a B L A o r N D A f o r a N C E . - E x p e r i e n c e i n t h e p r e p a r a t i o n a n d a s s e s s m e n t o f r e g u l a t o r y f i l i n g s , i n c l u d i n g I N D , N D A s , C T A s , a n d M A A s , i n t h e U . S . a n d p r e f e r a b l y t e r r i t o r i e s o u t s i d e t h e U S . -Must h a v e s t r o n g r e g u l a t o r y k n o w l e d g e o f d r u g d e v e l o p m e n t , i n c l u d i n g c l i n i c a l t r i a l s , m a n u f a c t u r i n g a n d p r e c l i n i c a l r e q u i r e m e n t s . -E x p e r t k n o w l e d g e o f F D A r e g u l a t i o n s , i n c l u d i n g G M P s , G L P s a n d G C P s . K n o w l e d g e o f f o r e i g n r e g u l a t i o n s i s a p l u s . -E x c e l l e n t w r i t t e n a n d v e r b a l c o m m u n i c a t i o n s k i l l s n e c e s s a r y . -M u s t b e a s t r o n g , o r g a n i z e d l e a d e r t h a t i s r e s u l t s o r i e n t e d , a b l e t o w o r k s u c c e s s f u l l y w i t h i n a t e a m e n v i r o n m e n t a n d a s a n i n d i v i d u a l c o n t r i b u t o r . -A b i l i t y t o p l a n a n d e x e c u t e c o m p l e x p r o j e c t s o n s c h e d u l e i n a m u l t i - p r i o r i t y e n v i r o n m e n t . –P r e v i o u s m a n a g e m e n t r e s p o n s i b i l i t i e s . E x p e r i e n c e i n l e a d i n g a n d m e n t o r i n g r e g u l a t o r y s t a f f . -P r o f i c i e n t u s e o f t e c h n o l o g y i n c l u d i n g M S O f f i c e S o f t w a r e P a c k a g e a n d I n t e r n e t r e s o u r c e s i s e x p e c t e d .Analytical Development, Staff to Senior Scientist______________________________________________(California)This newly created position will report to the leader of the Analytical Research group within Analytical Chemistry. Responsibilities: *technical leadership in the isolation, structural elucidation and quantification of drug impurities and degradation products; *performing and developing Mass Spectrometric, Chromatographic, NMR and other analytical techniques to provide full

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characterization of unknown small molecules; *writing technical procedures, technical reports and documents in support of our drug development projects; *optimizing techniques and identifying and implementing new technologies to enhance Analytical capabilities, (for example CE, SFC) with regard to the isolation, monitoring and identification of drug impurities and degradation products; *performing physical characterization of drug candidates (pH, pKA, solubility) as part of preformulation support; *managing multiple projects with minimum supervision and meeting internal and external client timelines with respect to data and reports; *interacting productively with colleagues on multidisciplinary drug development project teams to achieve project goals. Working on complex problems where analysis of situations or data requires an in-depth evaluation of many factors; *sustained demonstration of leadership qualities in technical proficiency, scientific creativity, collaborations with others and independent thought; *demonstrating commitment and enhanced efficiency in quantity and quality of work *maintaining familiarity with scientific literature. Possesses intellectual mastery in Analytical Chemistry. Qualifications and Other Required Knowledge and Skills:The ideal candidate should have a PhD or MS degree with at least five - ten years of relevant experience in GMP analytical method development/validation and ICH stability testing within the pharmaceutical industry. Expertise in HPLC and detector technology (such as UV, ELSD, RI or MS detectors), in modern data acquisition and in handling software is essential. Experience in development of IVIVC dissolution methods for IR/CR tablet formulations would be a plus. Good documentation, people management and communication skills will be required. Prior experience with analytical development for commercial or late-stage.Associate Director/Director, Group Leader in Analytical Development ____________ (California)We are currently seeking talented individuals with experience in an organization responsible for API and finished dosage form product and process characterization in a Research & Development environment to join our growing Pharmaceutical Operations team. Responsibilities include*Identifying, developing and implementing scientific and logistical activities specific to characterization of API and finish dosage forms for development programs; *Contributing to the development and implementation of procedures/guidances for associated characterization methods and in-house laboratory operations; *Providing oversight of CRO/CMO data generated on the behalf of company in cGMP laboratories; *Ensuring outputs from Analytical Development are generated in context of cGMP expectations; *Collaborating with others on basic research and development plans relevant to long-term objectives; *contributes to the working team for development activities specific to Pharmaceutical Operations (analytical, formulation and chemical development functions); *Having a proven track record of employee development specific to increasing the depth and breadth of Analytical Development; *Providing organizational management to 5-8 scientists; provides resource planning and manages recruiting initiatives to execute to the plan; *Contributing to project planning & budgeting to support group functions; *Providing content oversight for document generation of CMC source documents to support *IND/aIND/AR/NDA regulatory submissions.

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Qualifications and Other Required Knowledge and Skills:A PhD with 8+ years of related experience in Analytical/Physical Chemistry is required, with related industry experience in a cGMP environment. A solid publication record is a strong plus. A strong scientific understanding and expertise in the field of characterization science to support API and product development, from conception to full commercial utility, is required. A strong knowledge of current industry and regulatory trends in regard to science based approaches to developing pharmaceutical products and processes. Ability to work independently, think creatively, with excellent organizational, written and oral communication, leadership and problem solving abilities. A demonstrated track record of people management and development is strongly desired. A demonstrated track record of project management with focus on facilitative and organizational skills.

Sr. Director, Head of Analytical Department ____________________________________ (California)We are currently seeking talented individuals with experience developing or leading an organization responsible for API and finished dosage form product and process characterization in a Research & Development environment to join our growing Pharmaceutical Operations team.

Responsibilities:*Identifying, developing, implementing, maintaining and providing oversight for scientific and logistical activities specific to characterization of API and finish dosage forms for development programs *Contributing to the development and implementation of procedures/guidances for associated characterization methods and in-house laboratory operations*providing comprehensive oversight of CRO/CMO data generated on the behalf of company in cGMP laboratories *ensuring outputs from Analytical Development are generated in context of cGMP expectations; *collaborating with others on basic research and development plans relevant to long-term objectives; *contributing to leadership team for development activities specific to Pharmaceutical Operations (analytical, formulation and chemical development functions)*identifying and developing a work environment that supports appropriate employee development specific to increasing the depth and breadth of Analytical Development *providing organizational management to scientists; provides resource planning and manages recruiting initiatives to execute to the plan*High-level participation in project planning and departmental budgeting, including identifying, implementing and accountability for capital and service budgets to support group functions*Providing content oversight for document generation of CMC source documents to support IND/aIND/AR/NDA regulatory submissions.

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Requirements:A PhD with ten plus years of related experience in Analytical/Physical Chemistry is required, with related industry experience in a cGMP environment. A solid publication record is a strong plus. A strong scientific understanding and expertise in the field of characterization science to support API and product development, from conception to full commercial utility, is required. A strong knowledge of current industry and regulatory trends in regard to science based approaches to developing pharmaceutical products and processes.Ability to work independently, think creatively, with excellent organizational, written and oral communication, leadership and problem solving abilities. A demonstrated track record of organizational management and development, organizational effectiveness is strongly desired. A demonstrated track record of project management with focus on facilitative and organizational skills.

Clinical Pharmacology Study Manager / Associate Director____________________________________________________(Texas)Responsibilities: * Clinical pharmacology study design, protocol authoring, case report form design, study initiation, monitoring, and completion and reporting of clinical pharmacology studies. * Support product development, managing day-to-day study operations. * Provide progress reports and status updates; assess patient equability; validate and lock clinical databases; recruiting investigators. * Communicate effectively with other department personnel; CRO’S; IRB’s; and Phase I facilities. * Author CIB Clinical Pharmacology sections, CIB revisions, and IND or NDA submissions/updates. * Begin the process of contributing to the CP sections of briefing packages and global submission packages. * Represent Clinical Pharmacology at project meetings. * Manage other members of the Clinical Pharmacology group as assigned by management.Qualifications: * Bachelor's degree in an appropriate discipline with up to twelve years related experience to include six years of direct Clinical Research Scientist experience. * Master's degree with up to nine years of related experience to include four years direct related Clinical Research experience. * Ph.D. (Pharmacology, Pharmacokinetics, Biochemistry, Physiology) with up to six years of related experience to include four or more years experience as a Clinical Research Scientist experience. KEY FACTORS CANDIDATES MUST HAVE TO BE CONSIDERED: - Clinical Study Design - Protocol Authoring - Case Report Form Design - Study Initiation, Monitoring, and Completion - Database Cleaning - Site Close Out - College Degree - Management ExperiencePreformulations, Staff Scientist to Principal Investigator___________________________________________________(California)

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--Evaluating Physico-chemical and materials properties of small molecules and formulations, with a focus on solution and solid-state characterization and/or mechanical characterization; --Developing and evaluating small-scale formulations for oral and parenteral dosage forms for novel compounds to support PK and TK studies; --Interfacing with Basic Research and Preclinical Development to assess develop-ability of drug candidates; --identifying and developing small scale experiments to predict robustness of formulation and process upon scale-up; --Assessing materials properties of prototype formulations, and evaluating impact of excipient and API properties on formulation performance; --Assessing impact of processing on materials properties, especially the physical state of the API; --Contributing to the development of platform technologies for controlled release solid dosage forms with the main focus on roller compaction and fluid bed granulation; and --Troubleshooting formulations and suggesting options for resolution of any issues. Qualifications and Other Required Knowledge and Skills:A Masters with 10+ years of related experience or a PhD with 3+ years of related experience in Pharmaceutics, Physical Chemistry or Materials Science is required, with related industry experience in preformulation and/or Materials Characterization. A thorough understanding of solution and solid-state physics and chemistry applied to small molecule organics is essential. Working knowledge in X-ray Diffraction, Solubility and solubilization, Thermal analysis, Moisture sorption, IR/Raman spectroscopy, Optical and scanning electron microscopy and Liquid chromatography is required. A strong knowledge of Wettability, Particle Size Distribution, Granular Attrition, Flow and Segregation, Mechanical Characterization and Compaction simulation is strongly desired. Knowledge in properties essential for drug discovery is desired. Working knowledge in crystallization and salt/polymorph selection is preferred. A strong knowledge of surface phenomenon and colloidal science is preferred. Working knowledge of sustained release formulations, roller compaction and/or fluid bed granulation is preferred. A strong knowledge and research expertise in the field of solid oral dosage formulation is strongly desired, from conception to full commercial utility. Ability to work independently, with excellent organizational, communication, leadership and problem solving abilities. A demonstrated publication record and strong academic performance is required, with a significant publication record preferred.Manager, Biopharmaceutical Sciences____________________________________________________________________(Illinois)

Responsible for providing clinical expertise regarding pharmacokinetic (PK) and pharmacodynamic (PD) study conduct to LPT and GPT for multiple drug development programs with minimal management supervision. Responsible for clinical PK/PD study design, protocol preparation, implementation and study report preparation. Responsible for managing the activities of personnel associated with conduct of Clinical PK/PD studies and assurance of compliance with SOPs, and FDA and ICH regulations. Responsible, in cooperation with the assigned pharmacokineticist, for preparation and review of PK/PD components of Briefing Documents, INDs and NDAs.Responsibilities:

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PhD, PharmD, MS, BS in Pharmacy or life sciences with extensive training in pharmacokinetics and pharmacodynamics and data analysis. Must have 3-5 years of Phase I clinical PK/PD data analysis or equivalent. Knowledge of Clinical Research Organization industry for clinical trials. Knowledge of drug development process and ability to design and implement Clinical Pharmacology development plans. Proven project and time management skills 

Assistant Director, Project Management; Product Safety and Pharmacovigilance_________________________________(Illinois) Will be a member of the Product Safety and Pharmacovigilance senior leadership team, and have oversight and leadership of all projects1. Work closely with VP of PSP to ensure effective communication, implementation of vision and alignment with overall project management goals.2. Provide leadership, clear direction and deliver with quality on Project Management deliverables.3. Contribute actively to department goals and objectives by identifying project management opportunities.4. Elevate project and process related issues to VP, Safety Business Unit heads, and other stakeholders as needed.5. Facilitate resolution of cross-functional/ cross-site issues with functional Safety Business Unit heads.6. Work closely with Development project management staff to support joint projects, create /review project management reports, timelines and presentations, etc.7. Contribute cross-functional drug development and project management perspective at project management meetings and discussions with VP and Therapeutic Area Safety Business Unit Heads.8. Assign therapeutic area staff to projects based on priorities.9. Contribute to budget and staff discussions.10. Stay abreast of latest developments in the field of project management vis a vis drug development and contribute/ lead project management initiatives to improve efficiency and productivity.11. Help build a strong project management capability within PSP.Requirements: 1. Master's degree in Life Sciences or a related field, PhD/Pharm D preferred.2. Project Management Professional Preferred3. Advanced proficiency in project management and applies that knowledge to guide Product Safety and Pharmacovigilance functions, and Therapeutic Area teams.4. Able to act independently and interact with cross-functional TA Safety Business Unit Heads in the successful completion of major, complex deliverables.5. Ability to influence and motivate others both within and outside of direct reporting line authority.6. Advanced ability to interface effectively with all levels of Product Safety and Pharmacovigilance staff.7. Skilled in understanding, planning, and responding in highly ambiguous situations. Demonstrates a high degree of creativity, foresight and mature judgment in anticipating and solving complex and cross-project issues.

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8. Ability to organize, interpret, and communicate Therapeutic Area Safety Business Unit project management information both cross-functionally and to senior management within PSP.9. Ability to coach, motivate, communicate vision/mission, and provide technical advice to members in the department.10. Excellent facilitation, negotiation, problem-solving, and conflict resolution skills.11. Initiates and maintains extensive contacts within both internal and external networks.12. Excellent oral and written communication skills including the ability to present formally and informally within area of expertise to a diverse set of audiences, including senior management and external customers.13. Preferred experience: Working in a healthcare business setting with an emphasis in project management and team leadership roles (8 years), including experience operations and staff management experience (6 years). Experience working with cross-functional matrix teams and regulators and budget management experience highly desirable.

Senior Director, Risk Management______________________________________________________________________(Illinois) Responsible for ensuring development, execution, and communication of risk management strategies for Company’s products. The Senior Director, Risk Management Center, will have overall responsibility for the leadership and management of the Risk Management Center and for the development of global risk management plans. The Senior Director will ensure the partnership with appropriate departments and therapeutic area heads to ensure efforts are aligned to meet global clinical risk management strategies. This is a multi-dimensional role requiring outstanding "strategic thinking" skills. Requirements:1. MD or advanced health related sciences degree (PhD/PharmD); or equivalent.2. At least 10 years pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development, with at least 3-to-4 years of direct experience in risk management in a global setting preferred3. Key leadership responsibilities in previous role(s) preferred4. Global responsibilities in previous role(s) preferred5. Strategic thinking, Organizational, Leadership. Results-oriented performance. Team player.6. Excellent knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required).7. Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.

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8. Proven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist. 9. Excellent written and spoken English

Senior Development Analyst/Development Scientist I___________________________________________________(New Jersey) Bioanalytical Science Department is seeking an outstanding candidate to perform cGMP-regulated assays and to develop sensitive protein characterization assays using state-of-the-art analytical instrumentation. Candidate must have strong background knowledge of protein chemistry and hands-on experience and knowledge in protein characterization, using HPLC and mass spectrometry. Successful candidate will focus on the biochemical characterization of therapeutic antibodies in all stages of development, developing techniques and executing cGMP-regulated analytical assays. Candidate must be highly self-motivated, team-oriented, and goal-oriented with effective communication and interpersonal skills. Candidate will show record to demonstrate the willingness and ability to work as part of a larger multidisciplinary team of scientists.The essential duties and responsibilities are (but not limited to):1. Perform characterization analyses of monoclonal antibodies.2. Develop and qualify new or existing HPLC or 2D-LC and LC/MS based characterization methods.3. Develop and qualify cIEF method platform and assist tech transfer to QC.4. Characterize monoclonal antibodies using size exclusion chromatography with multiangle laser light scattering (MALLS) and reflective index (RI) detectors.5. Contribute to technical research reports, validation reports, and SOPs.6. Perform and follow cGMP regulatory guidance.7. Collaborate and support other groups and departments. Perform routine lab maintenance. Requirements:1. B.S., M.S. or Ph.D. in Biochemistry, Chemistry, or relevant disciplines. 2. B.S. (3+ yr.), M.S. (1+ yr), Ph.D. (0+ yr) of experience in state-of-the-art analytical techniques relevant to protein/glycoprotein characterization.3. Knowledge and/or hands-on experiences in cIEF, SDS-PAGE, HPLC and mass spectrometry for protein and peptide analysis.4. Knowledge and/or hands-on experience in biophysical characterization of protein is a plus.5. Strong organization and communication skills and effective interpersonal skills.6. Ability to learn new technologies and solve problems.7. Ability to work independently and in a team-oriented environment. 8. Ability to follow instructions and be attentive to details.

Senior Enzymologist Research Scientist/Research Investigator_____________________________________________(Colorado)Requirements: Strong interpersonal skills, initiative, and scientific excellence are imperative. Requires a Ph.D. plus postdoctoral experience. Drug discovery experience in an industrial setting is preferredDescription: We seek an exceptional scientist with extensive experience employing steady state and transient kinetics and/or biophysical techniques to characterize the interaction of

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small molecule inhibitors with their protein targets. The group is responsible for assay development, screening, lead validation, and lead optimization, working closely with structural biologists, protein chemists, computational and medicinal chemists in highly collaborative teams. The candidate would take a leadership role in these collaborative project teams in a fast paced drug discovery environment.

 Principal Scientist/Senior Manager/Assistant Director, CMC Technology________________________________(Illinois) Provide necessary technical CMC leadership for assigned global and local projects in Pharmaceutical Technology Management. This includes contributions to project strategy and tactics via internal project teams, as well as the selection and management of outside parties (laboratories, manufacturers) to support corporate development objectives.-Coordinates or directs the CMC activities between Company’s Pharmaceutical Technology Management and external development or contract organizations for assigned projects.-As required, coordinates or directs the CMC activities between Company’s Pharmaceutical Technology Management and other Company affiliates -Constructs and/or monitors CMC project timelines, identifies technical or resource issues, and takes remedial action if needed to prevent delays in timelines. Interacts with other project team members to resolve questions or issues as required assuring that project deliverables are on time.-From a technical standpoint, identifies, evaluates and selects appropriate organizations for development and commercial manufacturing activities. Coordinates these activities with those of other departments (Project Management, QA, Legal, Clinical, Regulatory Affairs etc.) as needed to assure that selection and implementation is efficient and effective.-Represents CMC Technology at project team meetings and provides strategic input regarding CMC development and manufacturing such that project team and corporate goals are met.-Writes or reviews CMC protocols and works with contract organizations to finalize the protocols and reports. To ensure the smooth transfer of CMC technology from originator to the selected end-user.-Monitors stability, analyzes the data, and predicts product shelf life.-Monitors technical aspects of production for both drug substance and drug product for development and commercial purposes. As needed, works with manufacturers to identify and correct process issues or inefficiencies which would result in organizational benefit.-Reviews/Writes substantial portions of CMC sections for regulatory submissions Requirements: -A M.S. or Ph.D. in Pharmacy, Pharmaceutics or Chemistry plus at minimum two (2) to seven (7) years of experience in the pharmaceutical development of investigational drug candidates is required. A B.S. in Pharmacy or Chemistry with additional relevant experience can be considered. -Experience with the development, scale-up and registration of oral solid or parenteral drug products preferred.-Excellent communication and project management skills are required as this position is responsible for the scientific evaluation and coordination of work performed by external organizations.-The ability to manage multiple projects and to work well within a team environment is also essential.-A working knowledge of cGMP requirements and FDA/ICH guidance is required, as well with commonly available computer tools such as the Microsoft (MS) Word, MS Excel, MS Outlook, MS Power Point and MS Project.-Title will be based on academic degree and depth and breadth of experience.

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Associate Director, Drug Development Project Management__________________________________________________________(Illinois)-Responsible for the logistical/tactical/strategic management of the local/global development teams, specifically, all logistics and analysis of critical path work plans essential to optimizing the time of development and to registration and launch of new products. -Directs others responsible for program management.-Focuses on assuring programs are moving swiftly to major milestones and major decision points without unnecessary delays associated with local/global/corporate strategies and/or planning. Reports speed bumps to management and recommends strategic solutions.-Chairs regular local program team meetings and establishes meeting schedule. Proactively anticipates program needs, both locally and globally. And schedules/chairs ad-hoc sub-meetings as necessary.-Coaches team excellence and speed along the development continuum.-Optimizes team understanding of program concepts with corporate goals – ensures team alignment around development/launch strategy, integrated program/product plan, to assure cross-functional integration of tasks and risk-management locally and globally. -Coaches team with goal of leading achievement and collaborating with dedicated members who can conceptualize both short-term and long-term objectives. This coaching role is organizational learning at work as a unique aspect of the DDPM leadership brand. -Direct/coach/supervise multi-disciplinary programs/program teams assigned to others. -Lead DDPM maturity model strategies focused on process improvements, system enhancements, industry benchmarking and organizational learning.-Lead global program teams and/or is member, secretary of chair of JDC.Requirements:Bachelors Degree. Advanced degree (masters, doctorate) a plus. Experience with global development required. Experience with co-licensing development desired. Total management experience including line/project management. Multidisciplinary program management experience, which includes leadership in more than one IND, NDA, Advisory Committee or other FDA meetings. More specific and expanded knowledge of at least three areas of drug development listed below:o Discovery o Chemistry, Manufacturing, Controls o Pharmacokinetics o Toxicologyo Pharmacology o Clinical Research o Study Design o Statistics – statistical programmingo Data management o Regulatory/Regulations o Regulatory/Submissions o Saleso Medical Writing/report writing o Manuscript/abstract writing o Medical Affairso Marketing/market research o Outcomes Research o Legal/Contracts/Confidentialityo Finance o Quality Assurance

Excellent understanding of required CMC, pharmacology, toxicology, PK, clinical requirements to support major US regulatory filings – IND, NDA.Leads preparation of FDA milestone meetings, such as Pre-IND, End-of-Phase II, Pre-NDA, Advisory Committees. Focus on strategic issues.Excellent understanding of the interdependencies of the various disciplines (CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance, etc) - what needs to be evaluated simultaneously vs.

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sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.Understanding of how to educate/advise others on Regulatory Guidances/Internal SOPs/PM concepts.

Assistant Director, Drug Development Project Management ___________ ____________________ (Illinois)Responsible for the project team to ensure adherence to the timeline and intervenes when necessary to identify and resolve issues in order to ensure timely completion of the drug development process. Duties: Coordinates the creation and maintenance of multi-disciplinary program plans. Strategically evaluates innovative alternative scenarios and “what-if” back-up plans.Prepares timelines for, and monitors and tracks all assigned projects, with clear focus on critical path issues and Go/No-Go decisions.Demonstrates a strategic understanding of local (US) issues affecting global development and global issues affecting local development.Schedules and chairs regular local program team meetings. Completes meeting minutes in timely fashion that accurately reflects status of program and outcomes of team progress/challenges.Communicates with key personnel and interacts with departments and/or companies regarding all relative information associated with each project. Develops and recommends business solution and actions toward solution.Disseminates project information/timelines to project team members in a timely manner and style that fosters teamwork.Assures that all departments have clear direction and deadlines for deliverables. Writes and reports periodic updates for management highlighting progress, obstacles and any remedial action proposed and taken.Alerts management to issues identified as problematic. Communicates with senior management to resolve issues pertaining to the timely completion of the drug development process. Lead multi-disciplinary program teams of professionals to strategically and expeditiously create and execute drug development plans.Coordinate/plan major activities necessary to submit IND/NDA/sNDA applications. Act as multi-disciplinary liaison.Participate in the Global Development (and/or Corporate Co-Development) activities with client company counterpart Japan, Europe and Canada, and function as liaison to ensure global harmonization, global planning, and team collaboration across the world.Requirements: Bachelors Degree. Advanced degree (masters, doctorate) a plus. Clinical development and/or project management experience preferred. In-depth knowledge of at least 3 areas (listed below) of drug development plus knowledge of entire drug development process.* Pharmacology * Clinical Research * Study Design * Statistics – statistical programming*Data management * Regulatory/regulations * Regulatory submissions * Medical writing/report writing * Manuscript/abstract writing * Medical Affairs * Marketing/market research*Outcomes research * Sales * Legal/contracts/confidentiality * Finance * Quality assurance

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Formulation Scientist / Sr Scientist / Principal Investigator ____________________ _____________________ (California)Responsibilities:Develop robust, stable, and bioavailable formulations to support Phase II and III clinical studies and commercialization. Develop and scale-up robust processes for the production of solid dosage formulations. Identify and collaborate with CROs/CMOs in the execution of clinical batches, and scale-up of formulation and processes to support late phase clinical studies and commercialization. Identify and develop platform technologies for sustained release formulations. Collaborate with QA and Analytical functions towards timely generation of regulatory documents. Qualifications and Other Required Knowledge and Skills:A BS/MS/PhD in Chemical Engineering, Chemistry, Materials Science or Pharmaceutical Sciences is required, with 10+/6+/3+ years of related industry experience in formulation design and development and process development and scale up. An in-depth knowledge and research expertise in the field of solid oral dosage formulation is strongly desired, from conception to full commercial utility. Strong knowledge of roller compaction and/or fluid bed granulation required. Working knowledge of sustained release formulations preferred. Familiarity and working knowledge of GMP/ICH regulations required, with experience working in a GMP facility preferred. Ability to work independently, with excellent organizational, communication, leadership and problem solving abilities. Working knowledge of quality by design and risk management is strongly desired. Knowledge of ICH Q8/Q9 and Q10 is preferred.Require solid dosage formulation experience and expertise in roller compaction, scale-up, fluid bed column coating or pelletization. 

Research Associate ll, Quality Control 2 positions (pre-IPO with 2 marketed products) ______________________ (California)The purpose of this position is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process and final products. Incumbent will be responsible for the following; Conduct laboratory tests in compliance with established Standard Test Methods and within regulatory and laboratory requirements; Assist in the development and improvement of written procedures and protocols. Maintain organized records of tests performed and results obtained. This may include maintaining a computer accessible database for the purpose of tracking and trending analytical data; Assist in performing laboratory investigations; and, Write investigation report as required. Requirements include 2 years of relevant hands-on laboratory experience and a BS degree in scientific discipline or equivalent experience. Ideal candidate will have: Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc; Good knowledge of cGMPs and laboratory practices; and, Proficient in the operation and maintenance of basic laboratory instruments and at least two major ones such as HPLC and GC.

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Associate Director / Team Lead, Clinical Pharmacology ____________ _ (Texas)- Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential.- Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis. - Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives. - Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products.- Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives. - Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies. - Submits and administers employee performance standards and actively develops personnel within the team.- Provides timely and quality documents (i.e., protocols, clinical study reports (CSRs), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects. - Represents Clinical Pharmacology at various clinical meetings and project team meetings.Principle Responsibilities:- Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and R&D objectives.- Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.- Provide effective and timely mentoring and support for subordinates. - Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.Additional (enhancing) skills:- Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation.- Familiarity with relevant SOPs and document management systems- Good knowledge of GCP requirements. - Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. - Excellent written and oral communication skills.

Senior Medical Writer (California)

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Contact for details

Staff Scientist to Senior Scientist, BioAnalytical _____________________________________________ (California)We have an immediate opening for an energetic and talented individual to develop and validate bioanalytical methods in a GLP environment for the determination of novel drug molecules and metabolites in biological matrices using HPLC and LC/MS/MS.Responsibilities include:Following appropriate SOPs, protocols, and other applicable regulations and providing timely analysis of biological samples from preclinical and clinical studies; Exercising independent judgment and creativity and applying strict evaluation criteria for obtaining results; Efficiently planning and scheduling work activities to ensure timely support for aggressive discovery and development programs; and Writing technical reports, preparing presentations, and contributing to regulatory filings as needed. Requirements:The ideal candidate will have extensive experience in GLP bioanalysis, including hands-on method development and assay validation, and a record of compliance with GLP systems and procedures. Extensive experience in LC/MS/MS is required, as is familiarity with related techniques (sample precipitation, SPE, liquid extraction, etc). Sound knowledge of current GLP regulations is required. Excellent communication and organizational skills and the ability to interact with multidisciplinary teams are essential. May supervise the activities of other lower level personnel. Requires a BA/BS or MA/MS degree or equivalent with five to eight (or more) years relevant experience.

Manager/Sr. Manager Technical Services________________________________________________________(California) Responsibilities: Understand, organize, and perform process validation in accordance with company and regulatory requirements.Execute study protocol Prepare data summaryHands on experience in operating lab and manufacturing equipment.Receive direct supervision from manager or engineer.Prepare formulations and perform physical testing for the productResponsible for process validation, process optimization, scale-up, technology transfer.Prepares process validation protocol and summary reports. Prepare and revise commercial MBRCollaborate and communicates effectively with PD, QA, QC, Manufacturing and Engineering departments. Provide trouble-shooting efforts (process & equipment) to support Manufacturing.Prepare study protocol to design and undertake quality scientific experimentation for the purpose of troubleshooting, scale up study or process optimization. Provide technical assessments in investigation reports. Conduct investigation to seek the root cause of deviation, OOT and OOS.

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Recommend the resolution from the investigation results, prepare the investigation report and implement the CAPA items.Review and approve process and equipment procedures and documentation per change control procedures. Develop relevant SOPsProvide training to associate or junior engineerProduct maintenance. Must work independently and manage multiple process validation projects, re-qualifications and change control issues.Write, review and approve various levels of documentation Be able to develop and build scale up models. Hold knowledge of Six Sigma and/or other statistical process control techniques and their requirements for the implementation during the process development. Be able to work in the laboratory, guide the conception and implementation of creative solutions to solve technical problems. Interpret results of experiments and make recommendations for process improvements that reflect understanding of regulatory requirements, business objectives, and cost implications.Supervise and train associate or engineer.Develop and maintain positive working relationships with other groupsKeep informed of industry trends, developments and new products in related process optimization and scale up. Take initiatives to improve production efficiencies, reduce cost of goods and optimize cycle time.Provide recommendation for the policy implementation.Support company’s Quality System.Requirements:Bachelor's degree in chemical engineering, pharmaceutics, or related science discipline and over 5 years of related experience, OR Master's degree or Ph.D. in chemical engineering, pharmaceutics, or science discipline; 2-6 years experience with MS or 0-5 years experience with PhDThorough knowledge of cGMP's and state-of-the industry practices in cGMP compliance.Strong verbal, presentation and technical writing skills. A proven track record of process development, process optimization and technology transfer experience. Effectively facilitate for positive conflict resolution. Ability to work with cross-functional team and meet performance commitments

Associate Director of Manufacturing___________________________________________________________________(California)Directs and coordinates activities of the manufacturing department to obtain optimum efficiency and economy of operations and maximize profits. Help design and implement effective communications over the operation in order to achieve continuity. Coaching the front line supervisors in how to lead in a more collaborative environment, and harnessing the full potential of all employees through team development efforts. Aids in formulating and administering organization policies by performing the following duties personally or through subordinate managers.

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Responsibilities: Other duties may be assigned.-Establishes and promotes the maintenance of a safe, accident free, and healthy work environment. Advocate of the Health, Safety, and Environmental Management System.-Ensure compliance with all city, county, state, federal regulations. Assure adherence to company policy and procedure.-Participates in formulating and administering company policies and developing long-range goals and objectives. Implement organization policies and goals. Plans, develops and recommends organization policies and goals to management.-Directs and coordinates activities of departments for which responsibility is delegated to obtain goals and objectives.-Reviews analyses of activities, costs, operations, and forecast data to determine department progress toward stated goals and objectives.-Confers with operations officer and other administrative personnel to review achievements and discuss required changes in goals or objectives resulting from status-Serves as member of management committees on special studies or projects-Coordinates activities of other departments such as Engineering, Planning, Warehousing, Sales, Quality or Research and Development, to affect operational efficiency and economy.-Assists in the coordinated promotion of products manufactured to develop new markets, increase share of market, and obtain competitive position in industry.-Confers with management personnel to establish manufacturing and quality control standards, develop budget and cost controls, and obtain data regarding types, quantities, specification, and delivery dates of products ordered.-Plans and directs manufacturing activities and establishes manufacturing priorities, in coordination with sales, in keeping with effective operations and cost factors.-Coordinates manufacturing activities with procurement, and quality control activities to obtain optimum manufacturing and utilization of human resources, machines, and equipment.-Reviews and analyzes manufacturing, quality control, maintenance, and operational reports to determine causes of nonconformity with product specifications, and operating or manufacturing problems.-Develops, implements, and reviews manufacturing costs and product quality, and develops or modifies operating methods and procedures designed to eliminate operating problems and enhance profitable operation of the plant.-Analyzes department budget requests to identify areas in which reductions can be made, and recommends an operating budget to senior management.-Confers with administrative personnel and reviews activity, operating, and sales reports to determine changes in programs or operations required.-Directs preparation of directives to department supervisors outlining policy.-Coordinates between the manufacturing, warehousing, and inventory control departments to insure smooth flow of quality products to meet customer requirements.-Oversees the various manufacturing/accounting systems to assure accurate and timely customer service, inventory control, and cycle counts.-Facilitates the continuous improvement effort in the areas of manufacturing, scheduling, warehousing, and inventory control, to optimize space utilization, inventory levels, and plant costs.-Participates as a member of the plant's Senior Management Team for facilitating team development at the plant in the areas of safety, quality, productivity, training, and reliability.

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Supervisory Responsibilities:-Manages subordinate supervisors who supervise employees in the Manufacturing Departments.-Is responsible for the overall direction, coordination, and evaluation of these units. -Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. -Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education And Experience:-Bachelor's degree (B. A./ B. S.) from four-year college or university; or a minimum of ten years related experience and/or training; or equivalent combination of education and experience.-Pharmaceutical manufacturing and a minimum of ten years progressive management experience required. -Business background and MRP II experience preferred.-Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. -Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. -Ability to effectively present information to top management and/or boards of directors.-Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. -Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.-Ability to define problems, collect data, establish facts, and draw valid conclusions. -Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee may occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations

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may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and fumes or airborne particles. The noise level in the immediate work environment is usually quiet.

***************************************************** For immediate consideration, please e-mail your resume to hr@impaxlabs.com.tw. Please also indicate the job title for which you would like to be considered

Impax Laboratories (Taiwan), Inc., a wholly owned subsidiary of Impax Laboratories, Inc., is located in Jhunan Science Park (竹南科學園區), Taiwan. Impax Laboratories, Inc. is a U.S. technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics and branded products. The pilot plant and manufacturing facility currently under construction at Jhunan site will produce oral solid products primarily for the U.S. market.

For individuals interested in gaining international experience by working and living in Taiwan, we offer the opportunity to join the fast growing team at Impax Laboratories (Taiwan), Inc. We have three newly created management positions for which we are seeking candidates fluent in both English and Mandarin. The job descriptions with related qualifications are listed below:

1. Director, QA/QC: Required Ph.D. in Chemistry or Pharmaceutical Science with at least 10 years or MS degree with 15 years of U.S. pharmaceutical industrial experience. In charge of QA and QC including Raw Material Group, Product Release, Stability/PV and Technical Service Support Group.

2. Manager, QC: Required Ph.D. in Chemistry or Pharmaceutical Science with at least 5 years or MS degree with 8 years of U.S. pharmaceutical industrial experience. Trouble-shooting and problem solving for raw material and finished product testing. In charge of three functions: Raw Material, Product Release and Stability.

3. Manager, Engineering: Required BS/MS in Engineering with at least 10 years of U.S. pharmaceutical industrial experience. Responsible for project engineering, equipment qualification; the operation and maintenance of process and critical utility equipment, as well as facilities and infrastructure maintenance for USFDA GMP Oral Solid Dosage manufacturing operation.

***************************************************** If you meet the requirements, please send your resume to ro contact: Ashley Whisnant   awhisnan@aerotek.com RecruiterAerotek Inc.

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2099 Gateway Place #750San Jose, CA 95110 Tel: 408-367-6788Senior Manufacturing Engineer- Aerotek SUMMARY/RESPONSIBILITIES: SUMMARY: This position will develop and implement manufacturing processes, equipment, and fixtures. Will work as part of a developmental team in developing and implementing new processes. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be included: Create documentation to support new and improved manufacturing processes Write and perform process validations Perform IQ/OQ/PQ as required on equipment. Disposition NCR's and CAPA's as assigned. Perform experiments including but not limited to DOE's to characterize and improve processes. Provide leadership and direction for more junior engineers in areas of manufacturing engineering and process development. Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis. Coordinate with the suppliers and external resources needed in developing and implementing new processes. Work closely between R&D and Manufacturing to capture and interpret the design intent in order to refine and improve processes. Facilitate excellent communications between all team members. EDUCATION/EXPERIENCE: Bachelor degree in engineering or equivalent experience. Minimum of five (5) years experience, preferably in a medical device environment Excellent hands-on communication and interpersonal skills Experienced in MS Word, Excel, and Project Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA). Experience with CAD Software (Solid Works & AutoCAD) preferred Supervisory experience preferred SUPERVISORY RESPONSIBILITIES: May supervise up to 3 engineers and/or technicians  ***************************************************** If interested or to submit your resume, please contact   Stephanie Miller {_smiller@robodoc.com_}Chief Financial Officer ROBODOC, a CUREXO Technology Company, Sacramento  Summary:The Chief Financial Officer provides hands-on leadership and holds the responsibility for overseeing the financial functions of the organization are performed in an environment of

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strict internal controls and recorded in accordance with Generally Accepted Accounting Principles (GAAP).  The responsibilities include planning, directing, and controlling the financial, strategic planning, and administrative affairs of the company.  As a member of the Senior Management Team, the CFO provides financial analytical services to the CEO/President, Senior Management Team and Board of Directors.   The position exists to ensure legal compliance with regulatory agencies.  It is critical that the financial policies and procedures align with company objectives.   Providing management with timely, accurate, financial and management information to properly assess the current and future operation, maximize profitability, and react to changes in the business and plan for the future operation of the company is essential.  In addition, short term and long term financial planning is imperative to ensure that the company achieves its return on investment goals. Duties and Responsibilities: Oversee the activities of the Controllership, and Information Systems departments.Direct the timely and accurate preparation of all financial and management reports, including income statements, balance sheets, reports to shareholders, tax returns, and reports for government regulatory agencies in accordance with the requirements of a publicly traded company. Ensure all financial and accounting activities are carried out with the highest degree of integrity, controls and ethical behavior and in accordance with regulatory requirements and accepted practices. Assist the CEO to issue press releases aimed at improving the company’s image and protecting its interests. Assist senior management in developing budget and profit and loss models for future periods. Oversee compilations of actual operational and financial results, to include budgeting, tax and audit activities. Interact with senior management and Board of Directors on various operational and financial matters. Review and analysis of operating and financial data for sales performance and trend analysis. Review and selection of company insurance coverage and policies.Maintain and control company contractual agreements.Primary interface to the public accountants of the company.Other duties as assigned.  Qualifications, Knowledge, Skills and Abilities: Bachelor’s degree in business or accounting, or equivalent combination of education and experience. MBA in accounting or business and/or CPA preferred.Excellent organizational skills. Ability to work with minimal supervision. Excellent oral and written communications skills. Proficient in MS Office.  Knowledge of EPICOR accounting system is a plus.Excellent interpersonal skills.  Must have the ability to interact well with all levels of internal management, staff, clients and vendors.Must maintain a high level of confidentiality.

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Minimum ten years accounting experience with increasing responsibilities to include controllership and CFO responsibilities.Significant business experience in accounting, financial controls, planning and analysis, financial systems, contract negotiations and risk management. Strong GAAP knowledge/experience.Prior experience in SEC reporting and Sarbanes-Oxley compliance.Strategic thinkerMedical device experience preferred *****************************************************  If interested or to submit your resume, please contact   Stephanie Miller [ smiller@robodoc.com ]Senior Level Sales and Marketing, ROBODOC 5.1 91208 Duties and Responsibilities:Develop and implement marketing strategy for US.  Drive Corporate and product branding and positioning initiatives within the U.S. as well as internationally and serve as the marketing interface with key thought-leaders. Oversee the US launch of the product and make sure all appropriate marketing materials are completeDevelop and implement a publication strategy designed to communicate the value of ROBODOC technology. Develop strong relationships with key decision makers and other influencers.Build and direct sales organization and select distributors to develop and implement leveraged educational activities within targeted markets. Serve as the resource for transferring branding, positioning, and product information associated with the use of ROBODOC technology to direct sales individuals and select distributors.Assess potential markets and channel strategies through financial and risk analysis, in support of the company's strategic plan. Write business plans that support extension of technology and product platforms into new opportunities for growth.Supervise marketing management in the development of promotional concepts, key messaging and program implementation including webinars, podcasting, print advertising, and promotional events.Leverage the skills and experience of the sales team to take ROBODOC to the highest levels.Create the systems, logistics and hire the necessary personnel to develop fully functional marketing teams.

Qualifications, Knowledge, Skills and Abilities:Minimum Bachelors Degree in Marketing or related field, MBA desirable. Strong Strategic Medical Device Marketing Experience- Minimum 5 yearsComprehensive Orthopedic Implant KnowledgeDemonstrated “hands on” Marketing experienceDocumented success in product launchStart up and large company experienceLarge capital equipment experience (CT, MRI, Imaging)

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Established orthopedic relationshipsLooking for a leader who is thoughtful, a visionary and decisiveHas a reputation for integrity and honestyIs a team player who can communicate directly Is a good listener, who welcomes, values and embraces best input for all levels of the organization  *****************************************************

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